Status:
COMPLETED
Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Idiopathic Rhinitis Patients
Healthy Controls
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
The term idiopathic rhinitis (IR) is used in this study to describe a patient group with following characteristics: patients with complaints of nasal obstruction, sneezing and/or rhinorrhea for a peri...
Eligibility Criteria
Inclusion
- Patients with persistent (\> 12w) rhinological symptoms: nasal discharge, sneezing, congestion for an average of at least 1 h per day for at least 5 days during a period of 14 days, negative skin prick test or negative RAST, and without structural abnormalities explaining nasal obstruction will be proposed to participate in the trial.
- Age \> 18 and \< 50 years
- Written informed consent
- Willingness to adhere to visit schedules
- Adequate contraceptive precautions in female patients with childbearing potential
- Unresponsiveness to nasal steroid spray (4 weeks of use)
Exclusion
- Age \< 18 and \> 50 years
- Patients with AR, demonstrated by either positive skin prick test or RAST
- Presence of IgE in nasal lavage fluid
- Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall.
- Systemic steroid treatment less than 4 weeks before the inclusion in the study.
- Nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
- Inability of the patient to stop taking medication affecting nasal function.
- Evidence of infectious rhinitis/rhinosinusitis.
- Pregnancy or breastfeeding.
- Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
- Enrollment in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
- Contra-indications for local anaesthesia (Cocaïne 5%).
- Smoking.
- Systemic disease with lesions in ENT domain.
- Malignancies or severe comorbidity.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01223820
Start Date
January 1 2011
End Date
September 1 2011
Last Update
October 3 2011
Active Locations (1)
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1
UZ Leuven, NKO-GH Kapucijnenvoer 33
Leuven, Vlaams-Brabant, Belgium, 3000